Cleared Traditional

K021644 - PERF (OMMAYA STYLE) RESERVOIRS

K021644 is an FDA 510(k) clearance for PERF (OMMAYA STYLE) RESERVOIRS, manufactured by Phoenix Biomedical Corp.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K021644 · Phoenix Biomedical Corp. · Neurology device
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Aug 2002
Decision
78d
Days
Class 2
Risk

K021644 is an FDA 510(k) clearance for the PERF (OMMAYA STYLE) RESERVOIRS. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Phoenix Biomedical Corp. (Valley Forge, US). The FDA issued a Cleared decision on August 6, 2002 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K021644

510(k) Number K021644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2002
Decision Date August 06, 2002
Days to Decision 78 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 149d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 250
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K021644.
ACCURA ELITE SHUNT SYSTEM
K024040 · Phoenix Biomedical Corp. · Jan 2003
PHOENIX UNIVERSAL SHUNT SYSTEM
K024101 · Phoenix Biomedical Corp. · Jan 2003
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K022554 · Integra Neurosciences · Aug 2002
CODMAN BACTISEAL EVD CATHETER SET
K021653 · Codman & Shurtleff, Inc. · Jul 2002
NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735
K021196 · Neuron Therapeutics, Inc. · Jul 2002
CODMAN HAKIM SHUNT SYSTEMS
K020667 · Codman & Shurtleff, Inc. · Mar 2002
K021644 · PERF (OMMAYA STYLE) RESERVOIRS
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